Devices for producing a tape product having diagnostic aids

ABSTRACT

A method for producing an analysis tape for fluid samples, in particular body fluids, is proposed. The method comprises providing a laminate tape having a laminate carrier tape and at least one diagnostic functional layer, and cutting the laminate tape in such a way that a diagnostic auxiliary label arises; transferring the diagnostic auxiliary label to a vacuum roller; and transferring the diagnostic auxiliary label to a carrier tape. In general, at least one vacuum roller is used for the transfer of the diagnostic auxiliary label to the carrier tape. The cutting of the diagnostic functional layer is effected in such a way that a free end of the diagnostic functional layer is lifted off from the laminate carrier tape by guiding the laminate carrier tape around a cutting edge with a small radius, wherein the diagnostic functional layer is cut at a predetermined distance from the lifted off free end by means of a cutting device.

CLAIM OF PRIORITY

The present application is a continuation based on and claiming priorityto Application No. PCT/EP2008/064614, filed Oct. 28, 2008, which claimsthe priority benefit of European Application No. 07119459.1, filed Oct.29, 2007, each of which are hereby incorporated by reference in theirrespective entireties.

TECHNICAL FIELD OF THE INVENTION

The invention relates to a method for producing an analysis tape forfluid samples, in particular body fluids. The invention furthermorerelates to a device for producing an analysis tape for fluid samples, inparticular using a method according to the invention. Methods anddevices of this type are generally used for example to produce a tapeproduct comprising diagnostic aids, for example diagnostic aids for asingle use. Diagnostic aids of this type can comprise in particular oneor more test fields with a detection chemical and/or lancets forobtaining a fluid sample of a body fluid, such as are used in thecontext of diabetes diagnostics, for example. Other fields ofapplication are also conceivable, however.

BACKGROUND

The examination of blood samples or other samples of body fluids, suchas interstitial fluid, for example, enables, in clinical diagnostics,early and reliable identification of pathological states and targetedand astute monitoring of body states. Medical diagnostics generallypresupposes that a sample of blood or interstitial fluid is obtainedfrom the patient to be examined. In order to obtain the sample, the skinof the person to be examined can be perforated, for example at thefinger pad or the ear lobe, with the aid of a sterile, pointed or sharplancet in order thus to obtain a few microliters of blood or less foranalysis. In particular, this method is suitable for an analysis of thesample which is carried out directly after the sample has been obtained.Primarily in the field of so-called “home monitoring”, that is to saywhere medical laypersons themselves carry out simple analyses of bloodor interstitial fluid, in particular for diabetics obtaining bloodsamples on a regular basis, several times a day, to monitor the bloodglucose concentration, lancets and associated devices (so-calledpuncturing aids) are offered. These are described for example in WO-A98/48695, U.S. Pat. No. 4,442,836, U.S. Pat. No. 5,554,166 or WO2006/013045 A1.

Self-monitoring of blood sugar levels is a method of diabetes controlthat is nowadays applied worldwide. Blood sugar devices in the prior artgenerally have an analysis device into which a test element (for examplea test strip) is introduced. The sample to be analyzed is applied to atest field of a test element and reacts in the test field with one ormore reagents, if appropriate, before it is analyzed. Optical, inparticular photometric, and electrochemical evaluation of test elementsare the most common methods for rapidly determining the concentration ofanalytes in samples. Analysis systems comprising test elements forsample analysis are generally used in the field of analysis,environmental analysis, and primarily in the field of medicaldiagnostics. Test elements which are evaluated photometrically orelectrochemically are of great significance particularly in the field ofblood glucose diagnostics from capillary blood.

The prior art discloses various forms of test elements and test devicesfor the evaluation thereof. By way of example, strip-type test elementscan be used, such as are described for example in the documents CA2311496 A1, U.S. Pat. No. 5,846,838 A, U.S. Pat. No. 6,036,919 A or WO97/02487. Further multilayered test elements known in the prior art areanalysis tapes comprising a multiplicity of test fields which areprovided in a cassette in a manner wound up for use in an analysisdevice. Such cassettes and analysis tapes are described for example inthe documents DE 10 332 488 A1, DE 10 343 896 A1, EP 1 424 040 A1, WO2004/056269 A1 and US 2006/0002816 A1. Besides analysis tapes comprisingtest fields, analysis tapes in which lancets are arranged on a carriertape have also become known in the meantime, wherein the individuallancets, by means of tape transport, can be progressively used and alsodisposed of again. One example of a system of this type is shown in WO-A2005/107596. Hereinafter, therefore, an “analysis tape” is understood tomean a tape with any desired type of diagnostic aids, wherein thediagnostic aids can comprise any desired type of diagnostic aids, forexample diagnostic test fields with a detection chemical and/or lancets.

Various methods are known for producing the analysis tapes. Thesemethods have to satisfy numerous stringent requirements since, in thefield of medical diagnostics, stringent requirements are made forexample of freedom from contamination for the analysis tapes, and alsostringent requirements are made of the quality and the reproducibilityof the diagnostic aids applied on the analysis tapes. At the same time,however, the analysis tapes have to be produced cost-effectively sincemedical diagnostics is under constantly increasing cost pressure.

EP 1 593 434 A2 discloses a method and a device for producing ananalysis tape for fluid samples. In this case, a rollable transport tapeis provided with a multiplicity of test fields situated at a distancefrom one another in the direction of the tape for analyzing the fluidsamples, in which case a multilayered test label tape is prefabricatedat least from a detection film and an adhesive tape and the test fieldsare subsequently transferred as self-adhesive test labels from the testlabel tape to the transport tape. For this purpose, it is proposed thata multitrack label tape is subdivided into multiple test labels insections by stamping and removing a stamping grid, said multiple testlabels subsequently being transferred to the transport tape in alabeling method.

This known method allows cost-effective and precise production ofhigh-quality analysis tapes. It has been found here during use inpractice, however, that the analysis method described in EP 1 593 434 A2is restricted in terms of throughput, such that labeling toleranceswhich exceed the predetermined maximum tolerances may occur at tapespeeds of the carrier tape of tens of m/min.

A further disadvantage of the known labeling methods, such as the methodknown from EP 1 593 434 A2, for example, is that large amount of rejectsarise during labeling. Thus, by way of example, the stamping and removalof the stamping grid as described in EP 1 593 434 A2 are associated withconsiderable rejects, which, in view of the high quality of the testchemical used and the complex construction of the multitrack label tapeused, considerably increases the production costs.

Therefore, it is an object of the present invention to provide a methodfor producing an analysis tape and also a corresponding device whichavoid the disadvantages of known methods and devices. In particular, themethod is intended to be suitable for production with a high throughput,good precision and low defect tolerance being achieved even at highthroughputs.

SUMMARY

This object and others that will be appreciated by a person of ordinaryskill in the art have been achieved according to the embodiments of thepresent invention disclosed herein, including the features of theindependent claims and other features realized individually or incombination, such as may be presented in the dependent patent claims.All of the claims are hereby incorporated in the content of thedescription.

A method for producing an analysis tape for fluid samples, in particularbody fluids, is proposed. The analysis tape is intended to have at leastone diagnostic and/or therapeutic function and can comprise inparticular at least one diagnostic aid for this purpose. In particular,said diagnostic aid can be a diagnostic test field with a detectionchemical designed to detect one or more analytes in the fluid sample. Byway of example, the test chemical can change at least one detectablephysical and/or chemical property if it comes into contact with theanalyte to be detected. In particular, an optically detectable property(for example a color change and/or a change in a fluorescence property)and/or an electrochemically detectable property can be involved.

As an alternative or in addition, the at least one diagnostic aid canfurthermore comprise a lancet designed to perforate part of thepatient's skin in order to produce a fluid sample. In this case, testfields and detection chemicals known from the prior art (for example inaccordance with the prior art described above) and/or lancet types knownfrom the prior art (for example in accordance with the prior artdescribed above) can be used. It is possible to use analysis tapes whichcomprise exclusively diagnostic test fields and/or exclusively lancets,wherein the test fields and/or lancets can be arranged for example atregular distances on a carrier tape. However, analysis tapes comprisingtest fields and lancets which are arranged alternately, for example, arealso conceivable. In this way, by way of example, by means of theanalysis tape, firstly a blood sample or some other sample of a bodyfluid can be generated using a lancet, after which this fluid sample canbe analyzed for example with the assistance of a test field adjacent tothe lancet on the carrier tape.

In the method proposed, a laminate tape comprising at least one laminatecarrier tape and at least one diagnostic functional layer is used as asemifinished product. The laminate carrier tape, which can comprise forexample a paper tape and/or a plastic tape and/or a multilayered carriertape, serves only as transport means of the actual diagnostic functionallayer and can subsequently be disposed of or reused, for example. Thediagnostic functional layer is adapted to the type of diagnostic aids tobe applied and can comprise for example a multiplicity of lancets and/orat least one detection chemical. In the latter case, the diagnosticfunctional layer can be configured for example as described in EP 1 593434 A2 and can comprise for example the test chemical in the form of adetection film. In addition, the diagnostic functional layer cancomprise further layers, such as adhesive layers (which can be arranged,for example, between lancet and/or test chemical and the laminatecarrier tape), for example, absorbent covering layers (for examplespiriting layers) and/or hydrophilizing and/or hydrophobizingimpregnations. Further layers, for example sealing layers for lancets orthe like, can also be included.

In the present invention, the diagnostic aids can be transferred to thecarrier tape in the form of diagnostic auxiliary labels in a rollmethod, for example in a manner similar to the method described in EP 1593 434 A2. For this purpose, the at least one diagnostic functionallayer of the laminate tape is firstly cut in such a way that adiagnostic auxiliary label arises. This diagnostic auxiliary label cancorrespond for example to the test labels in EP 1 593 434 A2 and can befor example a self-adhesive auxiliary label.

In contrast to EP 1 593 434 A2, however, the invention proposesimproving the transfer of the diagnostic auxiliary labels to the carriertape by using at least one vacuum roller. In this case, a vacuum rolleris understood to mean a roller which (for example through one or moresuction openings arranged circumferentially on the roller) can suck upan auxiliary label and transport it from the laminate tape to thecarrier tape by rotation of the vacuum roller. In order that theauxiliary labels are subsequently released again and applied to thecarrier tape, it is possible to utilize adhesion forces between theauxiliary label and the carrier tape, for example. If self-adhesiveauxiliary labels are involved, for example, then said adhesion forcesmay be greater than the suction forces of the vacuum roller, such thatthe auxiliary labels are released from the vacuum roller and applied tothe carrier tape.

As an alternative or in addition, however, the vacuum roller can also beconfigured in such a way that, by way of example, in the region of thecircumferential segment of the vacuum roller in which the auxiliarylabels are applied to the carrier tape, the suction to which theauxiliary labels are subjected is stopped. This can be done for exampleby interrupting the application of vacuum to the suction openings insaid region, or it is even possible to apply excess pressure in atargeted manner in said circumferential region, for example usingcompressed air.

Vacuum rollers are known from other fields of technology, in whichnon-medical products are produced. Thus, by way of example, U.S. Pat.No. 6,206,071 B1 describes a device which removes a “liner” from labelsand applies said labels to products. A vacuum roller is used in thiscase. WO 99/03738 also describes vacuum rollers, designated there astransfer cylinders, for use in labeling machines. Therefore, forpossible configurations of the vacuum roller in the context of thepresent invention, reference may be made to these two documents. Othertypes of configuration of the vacuum rollers are also conceivable, andcan be used in the context of the present invention.

It has been found in the context of numerous tests that the conceptaccording to the invention of using at least one vacuum roller for thetransfer of the auxiliary labels to the carrier tape affordsconsiderable advantages with regard to the precision with which theauxiliary labels are applied. While conventional labeling methods onlyenable slow tape speeds, it is possible by means of the method accordingto the invention to achieve tape speeds in the range of tens of m/minand labeling rates of up to 500 labels/min or more, where tolerances inthe sub-millimeter range (for example of at most 0.5 mm) can beachieved. Consequently, by means of the method according to theinvention, the throughput is increased, costs are reduced, and at thesame time a high quality of the analysis tapes produced is maintained orensured.

In addition to the method described, a device for producing an analysistape in accordance with the description above is proposed, which may besuitable in particular for implementing the described method or a methodin one of the modifications described below. In this respect, forpossible configurations, reference may largely be made to thedescription above and below, wherein the device can comprise in eachcase corresponding devices for implementing these individual optionalmethod steps.

The device comprises a labeling device, a laminate drive for supplyingthe laminate tape to the labeling device, a cutting device for cuttingthe laminate tape, in particular the diagnostic functional layer of thelaminate tape, a vacuum roller and a carrier drive for supplying thecarrier tape to the labeling device. The device is designed to transferthe diagnostic auxiliary label cut by the cutting device to the vacuumroller, wherein the carrier drive and the vacuum roller interact in sucha way that the diagnostic auxiliary label is transferred from the vacuumroller to the carrier tape. For the advantages of this device bycomparison with known devices, reference may largely be made to thedescription above.

The method described and the device described can be advantageouslydeveloped in various ways. Thus, the drives for the laminate carriertape or the laminate tape (laminate drive), the carrier tape (carrierdrive) and the vacuum roller (vacuum roller drive) can be synchronized.This synchronization has brought about in practice a considerable gainin the positioning accuracy of the diagnostic auxiliary labels and thusa significant increase in the tape speeds and the throughput. Thesynchronization can be effected mechanically and/or electronically, andit is also possible to combine two or more of the stated drives.

Suitable drives include electric motors, for example, in particularpowerful servomotors, which achieve the stated accuracies. Thus, it ispossible to use three servomotors, for example, which can be driven viaa BUS system. A specific high power SPC, for example, can function asinstallation controller. On account of the high transport speed of thelaminate carrier tape and/or of the carrier tape, the reaction times ofthe SPC controller should be extremely low. Moreover, the reaction timeper cycle should always be of identical length in order to be able toachieve an exact synchronization of the drives in the case of variablespeeds, since, by way of example, 1 ms switching time at the speed ofapproximately 55 m/min means a positioning tolerance of 1 mm in thedirection of travel.

As an alternative or in addition to synchronization of the drives, theat least one cutting device used for cutting the auxiliary labels canfurthermore be synchronized with one or more of the drives. The cuttingdevice can comprise a laser, in particular, for example a CO2 laser,which brings about a particularly high cutting accuracy, a high cuttingspeed and little cutting waste of the auxiliary labels. Such a cuttingdevice which comprises at least one laser can be synchronizedparticularly easily since it is merely necessary to switch the laser onand off and/or to block or release the laser beam and/or to deflect thelaser beam.

The cutting of the diagnostic functional layer can be effected, inparticular, in such a way that a free end of the diagnostic functionallayer is lifted off from the laminate carrier tape by guiding thelaminate carrier tape around a cutting edge with a small radius (forexample a radius of less than 10 mm, in particular less than 5 mm). Inthis case, the lifted off diagnostic functional layer can then be cut ata predetermined distance from the lifted off free end by means of thecutting device. By way of example, it is possible once again for labelsto be cut out or it is possible simply for a section of the lifted offdiagnostic functional layer to be completely lifted off. The lifted offfree end of the diagnostic functional layer can be applied to the vacuumroller before, during or directly after cutting, such that, aftercutting, the cut off auxiliary label is applied completely to the vacuumroller. The cutting can be effected in particular in the region of thecutting edge, for example within an air gap between the cutting edge andthe surface of the vacuum roller.

In contrast to known labeling methods, such as the labeling methoddisclosed in EP 1 593 434 A2, for example, the cutting in the methodproposed can be carried out in particular in a manner substantially freeof losses. In this case, “in a manner substantially free of losses”should be understood to mean a process of cutting in which, apart fromthe cutting waste resulting from the cutting device (which may typicallybe in the range of approximately 1/10 mm), no waste arises which, asdescribed in EP 1 593 434 A2, would have to be segregated. Therefore,from its free end, the diagnostic functional layer in one embodiment iscompletely cut up into auxiliary labels by cutting off an auxiliarylabel from said lifted off diagnostic functional layer, generally at apredetermined distance from said lifted off free end, and transferringto the vacuum roller. This means a considerable advantage overconventional labeling methods, such as not only the method described inEP 1 593 434 A2, but also for example the labeling methods in accordancewith U.S. Pat. No. 6,206,071 B1 or other known labeling devices, notonly since the segregation in practice can cause considerable technicaloutlay but since now the cost intensive diagnostic functional layer canbe completely utilized.

Further advantageous configurations concern the tape guidance of thelaminate tape or laminate carrier tape and/or of the carrier tape. Thus,for better guidance by means of the drives mentioned, the laminatecarrier tape and/or the carrier tape can be charged electrostatically,for example, in order to ensure better adhesion for example on one ormore rolls of the drives.

In other embodiments, the method and the device are configured in such away that always in each case one diagnostic auxiliary label is appliedsimultaneously on the vacuum roller. This simplifies the transfer andincreases the positioning accuracy.

A further improvement in the positioning accuracy concerns theconfiguration of the guidance and the drive of the carrier tape at thelocation where the diagnostic auxiliary label is transferred, that is tosay at the location of the labeling device. Thus, in particular, thecarrier tape can be guided in planar fashion at this location, forexample using a support on a side opposite to the labeling side of thecarrier tape, which has a counterpressure with respect to the vacuumroller. It is possible, however, to provide an application roller atthis location where the diagnostic auxiliary label is transferred to thecarrier tape, wherein the carrier tape is guided through a roller gapbetween the application roller and the vacuum roller. In this case, thecarrier tape can be guided in planar fashion by means of the applicationroller, that is to say without significant deflection by the applicationroller. It is possible, however, for the application roller to beconfigured in such a way that the carrier tape at least partly followsthe circumference of the application roller, that is to say is deflectedby said application roller. In this case, the application roller can bea part of the drive of the carrier tape. This development of theinvention has the advantage that the drive of the carrier tape iseffected directly at the location where the auxiliary labels areapplied, such that, by way of example, stretching effects of the carriertape are only of slight significance. The spatial uniting of drive andapplication location of the auxiliary labels thus brings about aconsiderable improvement in the accuracy of the positioning of theauxiliary labels on the carrier tape.

A further advantage of using a vacuum roller for applying the auxiliarylabels to the carrier tape consists in the possibility of effectingcorrective intervention in the application. This is advantageous inparticular since quality assurance is of considerably highersignificance in the production of medical products than in the field ofconventional labeling machines in which all labels are applied noncritically and without consideration of the quality thereof to anarticle to be labeled.

Thus, in particular, the vacuum roller can be utilized for dischargingdefective auxiliary labels and/or defective sections of the diagnosticfunctional layer from the production process. For this purpose, by wayof example, the diagnostic functional layer and/or other regions of thelaminate tape can be provided with a defect marking that identifiesdefective sections of the diagnostic functional layer. These defectmarkings can be applied for example by virtue of the fact that thedevice described has a defect identification device and/or a markingdevice. The defect identification device can be configured for examplein such a way that the diagnostic functional layer and/or the laminatetape can be examined for defects optically and/or electrically and/or insome other way. By way of example, it is possible in this way toidentify a discoloration of a test chemical and/or an incorrectpositioning of lancets on the laminate tape. The defect marking devicecan be used to correspondingly mark the laminate tape and/or thediagnostic functional layer if defects of this type are identified.Thus, by way of example, defect markings can be printed onto thelaminate tape and/or the diagnostic functional layer and/or adifferently designed marking of the defects can be effected. By way ofexample, it is possible to use a test chemical itself by the action of amarking beam, for example of a light beam (e.g. in the visible and/orultraviolet spectral range). In this way, by way of example, defectivesections of the generally light-sensitive test chemical can be coloredin order in this way to identify these sections as defective.

The device can furthermore have a detection device in the region of thelabeling device (that is to say for example in direct proximity to thevacuum roller), said detection device identifying the defect marking. Byway of example, said detection device can be an optical and/orelectrical detection device, which is specifically adapted to the defectmarkings and thus identifies printed-on defect markings and/ordiscolored regions in the test chemical, for example.

The vacuum roller used permits particularly simple discharge of suchdefective sections of the diagnostic functional layer. Thus, sectionswhich have been identified as defective before or after application tothe vacuum roller can be removed and disposed of, for example. For thisremoval of defective sections, the device can have a withdrawal device,for example, where various devices can be used as withdrawal device.Thus, it is possible to effect the removal of the defective sectionsfrom the vacuum roller for example electrostatically, mechanically or insome other way. It is possible for an extraction device using suction tobe used, which is utilized for removing the defective sections and whichis triggered by the detection device, for example, as soon as a sectionidentified as defective of the diagnostic functional layer isidentified. Such extraction by suction can be effected within fractionsof a second, such that the production process as a whole need not beinfluenced, or need be influenced only to an insignificant extent.Moreover, the extraction device using suction affords the advantage thatcontaminants can also be removed at the same time as or in addition todefective sections of the diagnostic functional layer, with the resultthat a problem of contamination can be significantly reduced.

As described above, the diagnostic auxiliary labels can comprise one ormore diagnostic aids which are applied to the carrier tape at regulardistances for example by the method described. It is possible for thediagnostic auxiliary labels each to comprise a plurality of diagnosticaids of this type, such as a plurality of identically designeddiagnostic aids. In this way, the method described can be rationalizedfor example by virtue of the diagnostic functional layer of the laminatetape having a plurality of tracks of diagnostic aids arranged in aparallel fashion in a running direction of the laminate tape, such that,during the process of cutting the diagnostic functional layer, thediagnostic auxiliary label that arises in the process has a plurality ofdiagnostic aids which are then applied to the carrier tape in anarrangement perpendicular to the carrier tape running direction. Thecarrier tape can then be cut into a plurality of sub-tapes for exampleby means of a mechanical or optical cutting process, wherein, by way ofexample, each of said sub-tapes comprises a diagnostic aid of eachdiagnostic auxiliary label. Said sub-tapes can subsequently be used asactual analysis tapes. This described method of cutting into a pluralityof sub-tapes can be configured for example analogously to the cuttingmethod described in EP 1 593 434 A2.

Furthermore, the method can be developed by virtue of the carrier tapecomprising additional markings. These markings can be applied to thecarrier tape for example by means of a rotary screen printing methodand/or some other printing method or coating method, typically beforethe auxiliary labels are applied to the carrier tape. Thus, by way ofexample, positioning marks can be applied on the carrier tape, whichpositioning marks can be used in the content of the production methodfor the positioning of the auxiliary labels and/or can be used later forexample in an analytical test instrument for a positioning of thediagnostic aids within the instrument.

As an alternative or in addition, the carrier tape can furthermorecomprise reference marks for an optical calibration of the analysistape. In particular, it is possible to apply color markings on thecarrier tape, which enable a color balancing. This is advantageousparticularly when the analysis tape comprises diagnostic aids which areutilized optically, for example test chemicals which are utilized for anoptical analyte detection. Thus, the reference marks can comprise forexample white and/or black fields which can be utilized for such a colorbalancing and/or a calibration of light sources used (for examplereflectance measurements).

BRIEF DESCRIPTION OF THE DRAWINGS

The following detailed description of the embodiments of the presentinvention can be best understood when read in conjunction with thefollowing drawings, where like structure is indicated with likereference numerals and in which:

FIG. 1 shows an exemplary embodiment of an analysis tape which can beproduced according to a method according to the invention;

FIG. 2 shows an exemplary embodiment of a blood sugar test device with atape cassette containing an analysis tape;

FIG. 3 shows an exemplary embodiment of a laminate tape used in a methodaccording to the invention, in plan view;

FIG. 4 shows the laminate tape in accordance with FIG. 3 in a sectionalillustration;

FIG. 5 shows an exemplary embodiment of a carrier tape which can be usedin a method according to the invention with an applied diagnosticauxiliary label;

FIG. 6 shows an alternative exemplary embodiment to FIG. 1 of ananalysis tape with diagnostic auxiliary elements with lancets;

FIG. 7 shows a detail illustration of a diagnostic auxiliary element ofthe analysis tape in accordance with FIG. 6;

FIG. 8 shows an exemplary embodiment of a tape cassette for a diagnostictest tape on which diagnostic aids with test fields and diagnostic aidswith lancets are applied in alternating fashion;

FIG. 9 shows an exemplary embodiment of a device according to theinvention for producing an analytical test tape;

FIG. 10 shows a detail illustration of a labeling device of theexemplary embodiment in accordance with FIG. 9;

FIG. 11 shows a basic schematic diagram of the labeling device of thedevice in accordance with FIG. 10;

FIG. 12 shows a basic schematic diagram of an alternative exemplaryembodiment of a labeling device;

FIGS. 13 and 14 show different perspective illustrations of an exemplaryembodiment of a pressure control device; and

FIG. 15 shows a perspective illustration of an exemplary embodiment ofan outer part of a vacuum roller.

In order that the present invention may be more readily understood,reference is made to the following detailed descriptions and examples,which are intended to illustrate the present invention, but not limitthe scope thereof.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE PRESENT INVENTION

The following descriptions of the embodiments are merely exemplary innature and are in no way intended to limit the present invention or itsapplication or uses.

FIG. 1 illustrates one possible exemplary embodiment of an analysis tape110 such as is known from EP 1 593 434 A2, for example, and such as canbe produced for example by a method according to the invention describedbelow. The analysis tape 110 comprises a carrier tape 112, which can beconfigured for example as a carrier film in the form of a plastic film.Said carrier film can be made very thin, for example, with a thicknessof between 10 and 15 μm, for example, and can comprise at least oneplastic material, for example polyethylene.

A multiplicity of test fields 116 are applied on the carrier tape 112 ina manner spaced apart in a transportation direction 114. Of these testfields 116, which, by way of example, can be arranged at a distance of110 mm and can have a length in the transport direction 114 ofapproximately 15 mm, just one is illustrated in FIG. 1. It should beassumed hereinafter that the test fields 116 are configured fordetecting an analyte, in particular blood glucose, in body fluids, inparticular in blood.

The analysis tape 110 in accordance with the illustration in FIG. 1 cancorrespond for example to the exemplary embodiment in accordance with EP1 596 434 A2. In this exemplary embodiment, the test fields 116 form ineach case a diagnostic aid 118 and can be embodied in multilayeredfashion for example as self-adhesive test labels. They each comprise asection of an optional adhesive tape 120, of a film of a test chemical122 and of an optional absorbent covering layer 124 in the form of afabric. Said covering layer 124 serves to enable an applied liquidsample to be distributed uniformly on the test field 116 and is oftenalso designated as “sprite layer”. Outside the test chemical 122, saidcovering layer 124, which may have hydrophilic properties, is providedin regions with an impregnation 126, which may have hydrophobicproperties. By way of example, said impregnation 126 can be a printed-onwax layer which leaves free only a central detection zone 128 in theregion of the test chemical 122, within which the liquid sample canspread. The test chemical 122 is intended to be configured to change atleast one detectable property, for example an optical or electrochemicalproperty, if it comes into contact with the at least one analyte to bedetected. Test chemicals of this type are known from the prior art, forexample the prior art cited in the introduction.

FIG. 2 illustrates a blood sugar test device 210, in which the analysistape 110, accommodated in a tape cassette 212, can be used. In thiscase, the analysis tape 110 is wound on a good winding 214. By means ofa process of winding forward, the individual test fields 116 can beexposed in the region of a measuring head 216 in order to apply a bloodsugar drop for the determination of glucose. In this case, fluid istaken up in the central detection zone 128 of the covering layer 124,wherein the edge strips provided with the impregnation 126 delimit thespreading of fluid. On account of the multilayered construction, thetest fields 116 have a certain height, while the thin, flexible carriertape 112 in the intervening regions permits reliable sealing at sealingelements, such that secure magazination protected against ambientinfluences is possible. After use, the test fields 116 that have beenused are wound onto a poor winding 218 by the analysis tape 110 beingwound further and are thus securely and hygienically remagazination.

According to the invention, the production of the analysis tapes 110 isperformed by means of a roll-to-roll method, which is explained ingreater detail below with reference to FIGS. 9 to 12. Firstly, thecarrier tape 114 already described in FIG. 1 is used as a preliminaryproduct for the production of the analysis tape. A laminate tape 310 isused according to the invention as a second preliminary product. By wayof example, FIGS. 3 and 4 illustrate such a laminate tape for theproduction of diagnostic aids 118 with a test chemical 122. In thiscase, FIG. 3 shows a plan view of the laminate tape 310, whereas FIG. 4shows a sectional illustration along the sectional line A-A in FIG. 3.

As can be discerned from FIG. 4, the laminate tape has a laminatecarrier tape 312. This laminate carrier tape 312 can for example in turncomprise a plastic tape, for example once again a polyethylene film or asimilarly designed laminate carrier tape. The adhesive layer 120 isapplied to this laminate carrier tape 312, said adhesive layercorresponding to the adhesive layer 120 in FIG. 1 and, during the methodaccording to the invention, being concomitantly transferred from thelaminate carrier tape 312 to the carrier tape 112. The test chemical 122is applied to the adhesive layer in structured tracks, wherein thetracks extend parallel to a running direction 314 of the laminate tape310. In the present case, these tracks of the test chemical 122 have awidth of approximately 2 mm (the illustration in FIGS. 3 and 4 is onlyschematic and not true to scale) and are arranged equidistantly, with aninterspace of likewise approximately 2-3 mm. Overall, five strips oftest chemical 122 are provided on the laminate tape 310.

As described above, the test chemical strips 122 are covered with acovering layer 124 of a hydrophilic fabric. This covering is effected insuch a way that the covering layer 124 extends over the entire width ofthe laminate carrier tape 312. As described above, in each case alikewise strip-shaped impregnation 126 is additionally applied to thecovering layer 124 outside the test chemical 122, wherein a total of sixsuch strips of the impregnation 126 are applied, which likewise extendin the running direction 314. This application is effected in such a waythat edge regions 316 of the laminate tape 310 remain uncovered.

The adhesive layer 120, the test chemical 122, the covering layer 124and the impregnation 126 together form a diagnostic functional layer318. In the method described below, this diagnostic functional layer 318is cut along cutting lines 320 running perpendicularly to the runningdirection 314, whereas the laminate carrier tape 312 remains uncut. Inthis way, diagnostic auxiliary labels 322 are formed from the diagnosticfunctional layer 318 during the cutting process, said diagnosticauxiliary labels being transferred to the carrier tape 112.

FIG. 5 schematically illustrates such a carrier tape 112 with diagnosticauxiliary labels 322 adhesively bonded thereon. Once again only onediagnostic auxiliary label 322 of this type is shown; other auxiliarylabels 322 are arranged equidistantly with respect thereto.

Furthermore, it can be discerned in FIG. 5 that positioning marks 510are arranged on the carrier tape 112, said positioning marks merelybeing indicated schematically in FIG. 5. These positioning marks 510serve for example for the positioning of the test fields 116 in theblood sugar test device 210 in accordance with FIG. 2. Furthermore,these positioning marks can be used in the production method describedbelow. Alongside the positioning marks 510, in the exemplary embodimentillustrated in FIG. 5, the carrier tape 112 comprises in each casereference marks 512, for example in the form respectively of a white andblack bar applied perpendicularly to the running direction 514 of thecarrier tape 112, which can be utilized for a color balancing and/orreflectance balancing.

The diagnostic auxiliary label 322 comprises, in accordance with thestrip-type arrangement of the test chemical 122, in this exemplaryembodiment five diagnostic aids 118 in the form of test fields 116 whichare arranged parallel to one another alongside one anotherperpendicularly to the running direction 514. In a subsequent cuttingmethod, the carrier tape 112 produced in this way with the diagnosticauxiliary labels 322 applied thereon is cut along cutting lines 516which run parallel to the running direction 514 and are only indicatedin FIG. 5. Overall, in the present case, for example, six cutting lines516 of this type are necessary, along which the carrier tape 112 withthe auxiliary labels 322 applied thereon is cut into sub-tapes 518. Eachof these five sub-tapes 518 which arise in this case in FIG. 5 forms ananalysis tape 110, for example an analysis tape 110 in accordance withthe illustration in FIG. 1. In this way, therefore, five analysis tapes110 can be produced in parallel and simultaneously by means of theroll-to-roll method according to the invention.

The exemplary embodiments described above are examples in which theanalysis tape 110 exclusively comprises diagnostic aids 118 in the formof test fields 116. However, other types of diagnostic aids 118 are alsoconceivable and can be used in the context of diagnostics and/ortherapeutics in connection with an analysis tape 110. An exemplaryembodiment of an alternative analysis tape 110 is illustrated in FIG. 6.This analysis tape 110 once again has a carrier tape 112, to which, inthis exemplary embodiment, diagnostic aids 118 in the form of lancetpacks 610 each comprising a lancet 612 are applied equidistantly. Thelancet packs 610 are shown in an enlarged detail illustration in FIG. 7.The lancet packs 610, analogously to the diagnostic auxiliary labels 322in the exemplary embodiments described above, can likewise be fixed inthe form of labels on the carrier tape 112. On account of the flexibleand flat lancet packs 610, this results in a rollable analysis tape 110which can be inserted into a handheld device for automatic handling (forexample analogously to the handheld device illustrated in FIG. 8).

The enlarged view according to FIG. 7 reveals that the respective lancet612 is protected in a pocket 614 formed by the lancet pack 610. Thepocket 614 is formed by a film assembly comprising a base film 616 and acovering film 618. An extended pocket region 620 accommodates the lancettip 622 in a manner lying freely, while a proximal shaft section 624 ofthe lancet 612 is tightly enclosed. Machine handling even with verysmall needle elements is thus facilitated, without having to fear damageto the very sensitive lancet tip 622 and impairment of the sterilitythereof. A round lancet 612 oriented perpendicularly to the runningdirection 514 is provided in the embodiment shown. Other orientationsand/or shapings are also conceivable, for example in the form of a flatpuncturing element provided with a grooved capillary collecting channel.

FIG. 8 illustrates an exemplary embodiment of a tape cassette 212comprising an exemplary embodiment of an analysis tape 110, on whichdiagnostic aids 118 in the form of test fields 116 and lancet packets610 are applied in alternating fashion. Each lancet pack 610 comprises alancet 612, which can be configured as a flat lancet for example in thisexemplary embodiment and which, in principle, can be configuredsimilarly to the exemplary embodiment illustrated in FIGS. 6 and 7. Boththe test fields 116 and the lancet packs 610 can be applied in the formof labels to a carrier tape 112 of the analysis tape.

The tape cassette 212 once again comprises a good winding 214 as asupply reel for unused tape material and a poor winding 218 as a take-upreel for remagazination or disposal of used diagnostic aids 118. Theprovision of diagnostic aids 118 can be effected by progressive tapeadvance, typically in a handheld device, in order to enable a largelyautomatic measurement sequence. A handheld device of this type cancomprise for example an actuator for actuating the lancet 612respectively situated in an application position, and an evaluationdevice for evaluating (for example optically evaluating) the measurementof the analyte concentration by means of the respective test field 116situated in a measurement position. In the course of such a measurement,which can be performed actually by the patient on site, a thin coveringfilm (reference numeral 618 in FIG. 7) is slit open by the lancet 612and the lancet tip 622 is uncovered in the process. A puncturingmovement for example for pricking a finger can then be carried out bymeans of a suitable actuator. In this case, the proximal shaft section624 expediently remains connected to the film laminate, therebysimplifying the subsequent disposal of the lancet 612 on the carriertape 112.

The abovementioned diagnostic aids 118 which can comprise test fields116 and/or lancets 612 are only some of the many possible exemplaryembodiments which can be used for medical diagnostics and/ortherapeutics and for which the production method described below can beused. In addition, analysis tapes 110 can be used which can compriseother types of diagnostic aids 118 or combinations of such diagnosticaids 118.

FIGS. 9 and 10 show a device 910 according to the invention forproducing an analysis tape 110, for example an analysis tape 110 inaccordance with one of the exemplary embodiments described above, inperspective illustration. The device 910 in one embodiment isaccommodated in a housing 912, which can be discerned in FIG. 9 andwhich is equipped in particular with sheets tinted such that damage tothe light sensitive test chemical 122 as a result of UV light can beavoided.

In the device 910, a roll-to roll method is used to apply diagnosticaids 118 (not discernible in the figures) to a carrier tape 112. Itshould be assumed hereinafter that the diagnostic aids 118 are aids withtest fields 116, such that, with regard to the details of saiddiagnostic aids 118, reference may be made for example to thedescription of FIGS. 1, 3, 4 and 5. However, other types of diagnosticaids 118 can also be applied by means of the method.

In the method described, a laminate tape 310 is unwound from a laminatetape good winding 914 and fed to a labeling device 916, where, inaccordance with the method described below, the diagnostic functionallayer 318 is lifted off from the laminate carrier tape 312, and the usedlaminate carrier tape 312 is wound onto a laminate tape poor winding918. The movement of the laminate tape 310 is designated by thereference number 314 in FIG. 9. This movement is brought about bylaminate drives 920, which are merely indicated symbolically in FIG. 9.By way of example, a laminate drive 920 can be connected to the poorwinding 918 and/or to the good winding 914 and/or to one or moredeflection rolls 922 (which become transport rolls in this case). In thecase of the drive of the transport rolls or deflection rolls 922, forexample the laminate drive 920 can be arranged directly behind thedriven deflection rolls 922. The carrier tape 112 is driven in itsrunning direction 114, 514 by a carrier drive 924, which is likewiseonly indicated symbolically in FIG. 9. By way of example, an applicationroller 926 can be provided in the region of the labeling device 916,said application roller being driven by the carrier drive 924. As analternative or in addition, however, the carrier drive can comprise atother locations drives which advance the carrier tape 112.

The labeling device 916 of the device 910 is shown in an enlarged detailillustration in FIG. 10. It can be discerned here that the laminate tape310 is guided by means of deflection rollers 922 to a cutting edge 928.In this case, the laminate tape 310 is guided around a tip 930 of thecutting edge 928, said tip having a small radius. The tip 930 is alsoreferred to as “dispensing edge”. Afterward, the laminate tape 310 isguided along the top side of the cutting edge 928, where it is held by apress on roller 932, and, finally, is guided by means of furtherdeflection rollers 922 as a poor product to the laminate tape poorwinding 918 (not illustrated in FIG. 10). In this case, the poor productis now composed only of the laminate carrier tape 312, whereas thediagnostic functional layer 318 has already been dispensed during theprocess of winding onto the poor winding 218 occurs.

Furthermore, the labeling device 916 has a vacuum roller 934. The tip930 of the cutting edge 928 is arranged directly above said vacuumroller 934. The vacuum roller 934 has suction openings 936 on itscircumference. In this exemplary embodiment, the suction openings 936are configured in round fashion and are distributed in two rows arrangedin the circumferential direction with equidistant suction openings 936.However, other arrangements of the suction openings 936 are alsopossible, of course.

Furthermore, the device in FIGS. 9 and 10 has a cutting device 938. Inthis exemplary embodiment, said cutting device 938 is configured as alaser cutting device and comprises a CO2 laser that generates a laserbeam 940. Said laser beam 940 is merely indicated symbolically in FIGS.9 and 10 and is configured in such a way that it impinges on thediagnostic auxiliary labels 322 in the region of the tip of the cuttingedges 930. The exact functioning will be explained in greater detailbelow with reference to FIG. 11.

Furthermore, the device 910 in accordance with FIGS. 9 and 10 in thisexemplary embodiment has a withdrawal device 942, which is configured asan extraction device 944 using suction in this exemplary embodiment.This extraction device 944 using suction has an extraction connectingpiece 946 using suction, the opening of which is arranged in directproximity to the region in which the laser beam 940, the tip 930 of thecutting edge 928 and the surface of the vacuum rollers 934 meet. Theextraction connecting piece 946 using suction is equipped with a crosssection that suffices for sucking up the diagnostic functional layer318.

A detection device 948 is indicated merely symbolically in FIG. 10, saiddetection device comprising an optical detection device, for example,and being designed to identify defect markings on the laminate tape 310fed to the cutting edge 928. By way of example, said defect markings, asexplained initially, can be color markings (for example defect marksprinted on separately and/or discolorations brought about in a targetedmanner in the test chemical 122) which can be detected for example by acamera and/or some other type of detection device 948. The detectiondevice 948 can then be utilized for triggering the withdrawal device 942for example directly or indirectly. In this way, sections of thediagnostic functional layer 318 that have been marked as defective andidentified as such by the detection device 948 can be extracted bysuction before they are labeled onto the carrier tape 112.

In order to produce defect markings, either a corresponding defectidentification device and/or a defect marking device can be provided inthe device 910 illustrated in FIGS. 9 and 10, or, as an alternative orin addition, the defect marking can also be effected in a separateproduction process for the laminate tape 310. Thus, by way of example, alaminate tape 310 comprising such defect markings can already be appliedto the good winding 914. Thus, by way of example, a separate productiondevice for the laminate tape 310 can have a defect identification deviceand/or a defect marking device for producing defect markings. By way ofexample, the laminate tapes can be monitored and marked optically duringand/or after production. By way of example, the strips of test chemical122 can be checked optically for correct color and/or form. Other typesof defect checking are also possible.

In order to explain in greater detail the functional principle of thedevice 910 illustrated in FIGS. 9 and 10, reference is made to the basicschematic diagram in FIG. 11. This basic schematic diagram onlyillustrates the labeling device 916, which comprises the cutting edge928, the vacuum roller 934 and the application roller 926. Of thecutting device 938, which is likewise to be assigned to the labelingdevice 916, only the laser beam 940 is illustrated.

As can be discerned in FIG. 11, the laminate tape 310 is fed to the tip930 of the cutting edge 928. As a result of the sharp deflection of thelaminate tape 310 at said tip 930, a free end 950 of the diagnosticfunctional layer 318 is lifted off from the laminate carrier tape 312and sucked up by the vacuum roller 934. As a result of the correspondingtriggering of the cutting device 938, a cut is made at a preciselydefined distance from said free end 950 of the diagnostic functionallayer 318, such that a diagnostic auxiliary label 322 arises. Thisdiagnostic functional label is conveyed toward the carrier tape 112 bymeans of a rotation 952 of the vacuum roller. In one embodiment, thedrives of the carrier tape 112, of the laminate tape 310 and of thevacuum roller 934 are synchronized in such a way that precisely onediagnostic auxiliary label 322 is simultaneously applied on the surfaceof the vacuum roller 934.

The vacuum roller 934 has a pressure control device 954, which isillustrated symbolically by the designation “V” and “P” in FIG. 11. Saidpressure control device 954 controls the pressure at the suctionopenings 936 and alternately applies reduced pressure and excesspressure thereto. In this case, the pressure control by the pressurecontrol device 954 is configured in such a way that the diagnosticauxiliary labels 322, starting from application in the region of the tip930 of the cutting edge 928, are sucked up and kept in this state untilthey reach a roller gap 956 between application roller 926 and vacuumroller 934, at which location the diagnostic auxiliary labels 322 areapplied to the carrier tape 112. A pressure reversal is effected thereby the pressure control device 954, and an excess pressure is applied tothe suction openings 936 in order to release the diagnostic auxiliarylabels 322.

Possible configurations of the vacuum roller 934 and of the pressurecontrol device 954 can be gathered from the documents WO 99/03738 andU.S. Pat. No. 6,206,071 B1 already cited. FIGS. 13 15 illustrate afurther exemplary embodiment of a vacuum roller 934, on the basis ofwhich a possible functional principle of the pressure reversal will beexplained.

It can be seen from FIGS. 13 15 that the vacuum roller has two essentialparts: in addition to the pressure control device 954 shown in differentillustrations in FIGS. 13 and 14, it has an outer part 958. The pressurecontrol device 954 comprises a stationary inner part 960, which does notconcomitantly rotate in the device 910, but rather is arranged such thatit is positionally and rotationally fixed. The inner part 960 isconfigured substantially in cylindrical fashion with a tapered portion926, onto which the outer part 958 is pushed (from the right in FIGS. 13and 14). The outer part 958 is likewise configured in cylindricalfashion, but is embodied as a hollow cylinder and has at its right endin FIG. 15 (not discernible in the illustration) an opening dimensionedin such a way that the latter fits together with an accurate fit withthe outer circumference of the tapered portion 962 of the inner part960. The outer part 958 is fixed to a driven shaft (not illustrated),such that it can be driven by means of a vacuum roller drive (designatedsymbolically by the reference numeral 964 in FIG. 9). The outer part 958is closed at its end side 966, but has openings 968 serving for examplefor pressure relief during insertion of the inner part 960 and/or fixingof the driven shaft. FIG. 15 likewise reveals the suction openings 936,which, as already explained, are arranged in two rows running in thecircumferential direction in this exemplary embodiment.

FIGS. 13 and 14 show the inner part 960 in different perspectiveillustrations. These illustrations differ from one another in that, inFIG. 14, the inner part 960 is rotated by 180° about its longitudinalaxis in comparison with FIG. 13. In both cases it can be discerned thatthe inner part 960 has in this case three connection holes 972, 974 atits end side 970 remote from the tapered portion 962, said end side notbeing inserted into the outer part 958 in the assembled state. Of saidconnection holes, two connection holes 972 are configured as vacuumconnection holes, whereas in this exemplary embodiment one connectionhole 974 is designed as a compressed air connection hole. Accordingly,vacuum and compressed air are respectively applied to the connectionholes 972, 974, for example by means of correspondingly flexible orrigid lines. Instead of compressed air, by way of example, simply anormal pressure could possibly also be applied (e.g. by simply openingthe connection hole 974), or some other compressed gas could be applied,for example ultrapure air or an inert gas, such as argon or nitrogen,for example.

The vacuum connection holes 972 are connected to vacuum openings 976arranged circumferentially in the region of the tapered portion 962. Inthis exemplary embodiment, two vacuum openings strung together in thecircumferential direction are provided, which are respectively connectedto one of the connection holes 972. The vacuum openings 976 areconnected to a common depression 978, which is dimensioned in such a waythat vacuum can be applied to the suction openings 936 in this region.The circumferential region over which the depression 978 extends thusdetermines the angular range or circumferential region within whichvacuum is applied to the suction openings 936.

The compressed air connection hole 974 is connected to two compressedair openings 980, which can lie for example diametrically opposite thedepression 978. In this exemplary embodiment, said compressed airopenings 980 are embodied as circumferential slots which are in turnpositioned in such a way that they are congruent in part with thesuction openings 936. The circumferential extent of said slots of thecompressed air openings 980 thus determines the angular range over whichcompressed air is applied to the suction openings 936.

The outer part 958 is caused to rotate by the vacuum roller drive 964.As a result of this, since the inner part 960 is stationary, differentsuction openings 936 successively pass over the depression 978 and thecompressed air openings 980. When viewed in a positionally fixedfashion, vacuum application and compressed air application are alwaysarranged in the same angular position regions, such that the diagnosticauxiliary labels 322 are sucked up and released always in the sameangular position. Thus, by way of example, the depression 978 cansubstantially correspond to that region of the vacuum roller 934 whichis designated by “V” in FIG. 11, whereas the circumferential region ofthe compressed air openings 980 can substantially correspond to theregion designated by “P” in FIG. 11, in which case, naturally betweenthese regions “V” of suction and “P” of pressure application, there mayrespectively be intermediate regions in which neither vacuum norcompressed air is applied to the suction openings 936. It goes withoutsaying that other configurations of the vacuum openings 976, of thedepression 978 and of the compressed air openings 980 are alsoconceivable.

Finally, FIG. 12 shows a device 910 (only once again the labeling device916 thereof) in a detail illustration, this detail illustrationcorresponding to the basic schematic diagram in FIG. 11. Thisalternative embodiment substantially corresponds to the embodiment inaccordance with FIG. 11, such that reference may largely be made to thedescription above. However, differences arise in the guidance of thecarrier tape 112. While in FIG. 11 the application roller 926 has smalldimensions (for example smaller than the vacuum roller 934) and whilethe carrier tape 112 is guided substantially without deflection by theroller gap 956, the application roller in the embodiment in accordancewith FIG. 12 is designed as a deflection roller and is configured suchthat it is considerably larger than in FIG. 11, in particularconsiderably larger than the vacuum roller 934. In this exemplaryembodiment, the carrier tape is deflected by almost 180° by theapplication roller 926, such that it comes into contact with theapplication roller 926 in a large circumferential region. Consequently,the application roller 926 can be utilized not only for generating acounterpressure with respect to the vacuum roller 934, but also fordriving the carrier tape 112. For this purpose, the application roller926 can be connected to a carrier drive 924 and thus be configured as adriven application roller. This configuration has the advantage that thedrive of the carrier taper 112 is shifted to the direct vicinity of theapplication location of the diagnostic auxiliary labels 322 (which isarranged approximately in the roller gap 956). As a result, theprecision of the application of the diagnostic auxiliary labels 322 canbe considerably increased, whereby the passage speed of the carrier tape112 can in turn be increased. In order to improve the adhesion of thecarrier tape 112 on the application roller 926, the carrier tape canadditionally be charged electrostatically, which further improves theprecision of the carrier drive 924 and the guidance of the carrier tape112.

The figures do not illustrate a further cutting device, which canoptionally be provided for cutting up the carrier tape into sub tapesafter the application of the diagnostic auxiliary labels 322.Furthermore, it should be pointed out that the device 910 illustrated inthe figures, in one of the embodiments described, can be extended byadditional devices. Thus, instead of the application of a singlediagnostic auxiliary label 322 by a single labeling device 916, furtherlabeling devices 916 can be provided, wherein for example differenttypes of diagnostic auxiliary labels 322 with for example differenttypes of diagnostic aids 118 can be applied. Thus, by way of example, itis possible to provide a labeling device 916 in which diagnosticauxiliary labels 322 with lancets 612 are applied, and a subsequentlabeling device 916 in which diagnostic auxiliary labels 322 with testfields 116 are applied. Further elements can also be applied to thecarrier tape 112, for example covering layers, markings or the like.

The features disclosed in the above description, the claims and thedrawings may be important both individually and in any combination withone another for implementing the invention in its various embodiments.

It is noted that terms like “preferably”, “commonly”, and “typically”are not utilized herein to limit the scope of the claimed invention orto imply that certain features are critical, essential, or evenimportant to the structure or function of the claimed invention. Rather,these terms are merely intended to highlight alternative or additionalfeatures that may or may not be utilized in a particular embodiment ofthe present invention.

For the purposes of describing and defining the present invention it isnoted that the term “substantially” is utilized herein to represent theinherent degree of uncertainty that may be attributed to anyquantitative comparison, value, measurement, or other representation.The term “substantially” is also utilized herein to represent the degreeby which a quantitative representation may vary from a stated referencewithout resulting in a change in the basic function of the subjectmatter at issue.

Having described the present invention in detail and by reference tospecific embodiments thereof, it will be apparent that modification andvariations are possible without departing from the scope of the presentinvention defined in the appended claims. More specifically, althoughsome aspects of the present invention are identified herein as preferredor particularly advantageous, it is contemplated that the presentinvention is not necessarily limited to these preferred aspects of thepresent invention.

1-20. (canceled)
 21. A device for producing an analysis tape for fluidsamples, the device comprising: a laminate drive for supplying alaminate tape having a laminate carrier tape and at least one diagnosticfunctional layer to a labeling device; a cutting device for cutting thelaminate tape, wherein the cutting device cuts the diagnostic functionallayer so that a diagnostic auxiliary label arises; at least one vacuumroller, wherein the device transfers the diagnostic auxiliary label tothe vacuum roller; and a carrier drive for supplying a carrier tape tothe labeling device, wherein the carrier drive and the vacuum rollerinteract so that the diagnostic auxiliary label is transferred from thevacuum roller to the carrier tape, wherein the device cuts thediagnostic functional layer so that a free end of the diagnosticfunctional layer is lifted off from the laminate carrier tape by guidingthe laminate carrier tape around a cutting edge with a small radius, andwherein the diagnostic functional layer is cut at a predetermineddistance from the lifted off free end by means of a cutting device. 22.The device as claimed in claim 21 further comprising a vacuum rollerdrive for driving the vacuum roller, wherein the laminate drive, thecarrier drive and the vacuum roller drive are synchronized.
 23. Thedevice as claimed in claim 21, wherein the cutting device comprises aCO₂ laser.
 24. The device as claimed in claim 21 further comprising awithdrawal device comprising an extraction device using suction, thewithdrawal device configured to remove defective sections of thediagnostic functional layer before or after application to the vacuumroller.
 25. The device as claimed in claim 21 further comprising adefect identification device for identifying defective incipient cuts ofat least one of the diagnostic functional layer and the laminate tape.26. The device as claimed in claim 21 further comprising a defectmarking device for marking defective incipient cuts of at least one ofthe diagnostic functional layer and the laminate tape.
 27. The device asclaimed in claim 21 further comprising in a region of the labelingdevice, a detection device for identifying incipient cuts of at leastone of the diagnostic functional layer and the laminate tape which havebeen marked as defective.
 28. The device as claimed in claim 21, whereinat least one of the laminate carrier tape and the carrier tape ischarged electrostatically.
 29. The device as claimed in claim 21,wherein the diagnostic auxiliary label comprises at least one diagnosticaid selected from the group consisting of a diagnostic test field with atest chemical designed to detect one or more analytes in the fluidsample; and a lancet designed to perforate part of a patient's skin togenerate a fluid sample.
 30. The device as claimed in claim 21, whereinthe at least one diagnostic auxiliary label is alternating lancets anddiagnostic test fields.
 31. The device as claimed in claim 22, whereinthe cutting device is synchronized with the laminate drive, the carrierdrive and the vacuum roller drive.
 32. The device as claimed in claim21, wherein the diagnostic functional layer includes defect markings formarking defective sections of the diagnostic functional layer, whereinsections marked as defective are removed before or after application tothe vacuum roller.